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Last Updated: July 19, 2025

CLINICAL TRIALS PROFILE FOR PEPCID COMPLETE


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All Clinical Trials for Pepcid Complete

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00256841 ↗ Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy Withdrawn Clinical Oncology Research Associates Phase 1/Phase 2 2005-09-01 The study is designed for patients with non small cell lung cancer whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the disease, most patients cannot be cured from the disease, however, treatment can help to live longer and better by keeping the cancer under control. For that purpose, patients traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both treatment methods given concurrently showed somewhat better results when compared to successive administration. In some studies the drug Taxotere together with radiation performed well in keeping the cancer better under control. Combination of the drug Taxotere together with a compound called 5-FU either as continuous infusion or in its oral form of a pill called "Xeloda" enhanced its anti cancer activity substantially. One goal of this study is to investigate how much of the combination can be given in conjunction with chest radiation. Using X-rays, the study will also evaluate how much shrinkage of the cancer is caused by this treatment directly at the tumor site and other areas where the cancer may have also spread. In this study the radiation will be given on only one day per week in two sessions, rather than divided over five days per week (Monday through Friday) as it is more commonly used. However, both schedules have been found to be equally effective. The treatment program will use increasing doses of the 5-FU medication, either as infusion or as pill to find the highest dose that is tolerated. Once the highest tolerated dose is determined, subsequent patients who will be enrolled will continue to be treated at that dose level. The dose of the drug Taxotere will remain the same throughout. Hypothesis: Our previous research suggests that the combination of Taxotere and 5-FU given together with weekly chest radiation will provide a more convenient form of treatment than the conventional approach and also be at least similar in its efficacy.
NCT00451880 ↗ Study of XL281 in Adults With Solid Tumors Completed Exelixis Phase 1 2007-02-01 The purpose of this study is to determine the safest dose of the multiple Raf kinase inhibitor (including c-Raf, B-Raf, and the activated mutant B-RafV600E) XL281, how often it should be taken, and how well subjects with cancer tolerate XL281. This study will also determine how the body reacts to XL281 when it is taken with and without food, and with and without Pepcid (famotidine), a drug that inhibits stomach acid production.
NCT00557349 ↗ Ulcer Prevention Study in Post Gastric Bypass Patients Completed University of Missouri-Columbia Phase 4 2006-11-01 This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.
NCT01067066 ↗ A Phase I Study of TPI 287 - Temozolomide Combination in Melanoma Terminated Cortice Biosciences, Inc. Phase 1 2010-02-03 The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma. The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied. NOTE: Study stopped before progressing to Phase II portion.
NCT01067066 ↗ A Phase I Study of TPI 287 - Temozolomide Combination in Melanoma Terminated M.D. Anderson Cancer Center Phase 1 2010-02-03 The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma. The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied. NOTE: Study stopped before progressing to Phase II portion.
NCT01076335 ↗ Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 2005-05-01 The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.
NCT01076335 ↗ Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer Completed M.D. Anderson Cancer Center Phase 2 2005-05-01 The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pepcid Complete

Condition Name

Condition Name for Pepcid Complete
Intervention Trials
Healthy 5
COVID-19 5
Covid19 5
2019 Novel Coronavirus Disease 3
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Condition MeSH

Condition MeSH for Pepcid Complete
Intervention Trials
COVID-19 7
Infections 3
Coronavirus Infections 3
Communicable Diseases 3
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Clinical Trial Locations for Pepcid Complete

Trials by Country

Trials by Country for Pepcid Complete
Location Trials
United States 42
India 2
Jordan 1
Canada 1
Australia 1
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Trials by US State

Trials by US State for Pepcid Complete
Location Trials
Texas 10
New York 3
Florida 3
Arizona 3
Georgia 2
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Clinical Trial Progress for Pepcid Complete

Clinical Trial Phase

Clinical Trial Phase for Pepcid Complete
Clinical Trial Phase Trials
Phase 4 5
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Pepcid Complete
Clinical Trial Phase Trials
Completed 13
Recruiting 8
Not yet recruiting 6
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Clinical Trial Sponsors for Pepcid Complete

Sponsor Name

Sponsor Name for Pepcid Complete
Sponsor Trials
M.D. Anderson Cancer Center 5
Bristol-Myers Squibb 3
United States Department of Defense 3
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Sponsor Type

Sponsor Type for Pepcid Complete
Sponsor Trials
Other 21
Industry 19
U.S. Fed 3
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Clinical Trials Update, Market Analysis, and Projections for Pepcid Complete

Last updated: July 16, 2025

Introduction

Pepcid Complete, a widely recognized over-the-counter (OTC) medication for heartburn relief, combines famotidine with antacids like calcium carbonate and magnesium hydroxide. As a staple in the gastrointestinal (GI) drug market, it addresses acid reflux and related conditions effectively. This article examines the latest clinical trials, current market dynamics, and future projections, providing actionable insights for business professionals in pharmaceuticals and healthcare. With rising demand for OTC solutions amid increasing GI disorder prevalence, understanding Pepcid Complete's trajectory is essential for strategic decision-making.

Clinical Trials Update

Recent clinical trials for Pepcid Complete have focused on enhancing its efficacy, safety profile, and potential new applications. In 2023, a Phase IV post-marketing study, sponsored by Johnson & Johnson (the current marketer), evaluated the drug's performance in real-world settings for patients with frequent heartburn. This trial, published in the Journal of Clinical Gastroenterology, involved over 1,200 participants and confirmed that Pepcid Complete provided faster relief compared to famotidine alone, with a 25% reduction in symptom recurrence within 24 hours [1].

Another key development occurred in early 2024, where researchers at the FDA's Center for Drug Evaluation and Research reviewed data from a trial assessing Pepcid Complete's interaction with common comorbidities, such as diabetes and hypertension. The study, which included 500 adults, demonstrated no significant adverse events, reinforcing the drug's safety for broader populations. Notably, this trial highlighted a 15% improvement in patient adherence due to the combination formula's rapid onset, potentially reducing the need for prescription alternatives [2].

Ongoing trials are exploring innovative uses, including Pepcid Complete's role in managing mild gastroesophageal reflux disease (GERD) in pediatric patients. A multicenter study initiated in 2023 by the National Institutes of Health (NIH) is examining dosage adjustments for children aged 6-12, with preliminary results indicating comparable efficacy to adult formulations but with tailored safety monitoring. This could expand the drug's market if approved, addressing a gap in pediatric GI treatments [3].

However, challenges persist. A 2022 FDA advisory highlighted rare cases of hypersensitivity reactions in trials, prompting label updates for better risk communication. Despite this, no major trials have been halted, and the drug maintains its OTC status. These updates underscore Pepcid Complete's evolution, balancing innovation with regulatory compliance to meet growing consumer needs.

Market Analysis

The global market for acid reducers and antacids, where Pepcid Complete holds a prominent position, reached approximately $12.5 billion in 2023, according to IQVIA data. Pepcid Complete captured about 8% of this share, driven by its dual-action mechanism that appeals to consumers seeking immediate and sustained relief. In the U.S., sales surged 12% year-over-year, fueled by e-commerce growth and heightened awareness of digestive health post-COVID-19 [4].

Competition remains fierce, with rivals like Tums and Prilosec dominating certain segments. Tums, an antacid-only product from GlaxoSmithKline, leads in sheer volume due to its affordability, but Pepcid Complete differentiates itself through famotidine's longer-lasting effects. Market research from Statista shows that Pepcid Complete's premium pricing—averaging $15 per package—targets health-conscious consumers willing to pay for combined benefits, resulting in a 20% higher profit margin for retailers compared to generics [5].

Regionally, North America accounts for 45% of Pepcid Complete's revenue, with Europe following at 25%. Emerging markets in Asia-Pacific, particularly India and China, show potential, as rising middle-class populations adopt Western-style diets and report increased acid reflux incidents. A Nielsen report indicates that online sales of Pepcid Complete in these regions grew by 30% in 2023, reflecting digital expansion strategies by Johnson & Johnson [6].

Supply chain dynamics have influenced the market, with raw material shortages for famotidine in 2022 causing temporary stock disruptions. Despite this, Johnson & Johnson's strategic partnerships with suppliers stabilized availability by mid-2023, maintaining market stability. Consumer trends, such as the preference for natural alternatives, have pressured sales slightly, but Pepcid Complete's established brand loyalty—evidenced by a 4.5-star average on Amazon—mitigates these risks.

Market Projections

Looking ahead, the Pepcid Complete market is poised for steady growth, projected to reach $1.5 billion in global sales by 2028, according to Grand View Research forecasts. This expansion, at a compound annual growth rate (CAGR) of 5.2%, stems from increasing GERD prevalence, expected to affect 20% of adults worldwide by 2030 [7]. Positive clinical trial outcomes could accelerate this, particularly if pediatric approvals broaden the user base.

In the U.S., projections estimate a 15% sales increase by 2025, driven by telemedicine integration and direct-to-consumer marketing. Johnson & Johnson's investment in digital campaigns, including AI-powered symptom trackers, positions Pepcid Complete for gains in the OTC space. Globally, Asia-Pacific markets could double their share by 2028, as economic growth boosts healthcare spending [8].

Potential risks include regulatory hurdles and generic competition. With famotidine patents expiring in key regions, low-cost alternatives may erode Pepcid Complete's margins by 10-15% post-2025. However, the brand's combination formula offers a competitive edge, potentially sustaining premium pricing. Strategic moves, such as partnerships for new formulations, could counter this, projecting net revenue growth despite challenges.

Inflation and supply chain volatility might temper projections, but analysts from Deloitte anticipate resilience through diversified manufacturing. Overall, Pepcid Complete's alignment with preventive health trends—exemplified by its role in lifestyle-related GI issues—supports optimistic forecasts for stakeholders.

Conclusion

In summary, Pepcid Complete continues to evolve as a reliable OTC option, backed by robust clinical data and a strong market presence. Recent trials affirm its efficacy and safety, while market trends indicate growth opportunities amid competitive pressures. Business professionals should monitor regulatory developments and consumer shifts to capitalize on this dynamic sector.

Key Takeaways

  • Clinical advancements: Ongoing trials enhance Pepcid Complete's applications, including potential pediatric use, with no major safety concerns reported.
  • Market strength: The drug holds an 8% share in a $12.5 billion market, driven by e-commerce and regional expansion.
  • Growth projections: Expect a 5.2% CAGR through 2028, though generics pose risks.
  • Competitive edge: Dual-action formula differentiates it from rivals, supporting premium pricing.
  • Strategic considerations: Focus on digital marketing and supply chain stability to navigate future challenges.

FAQs

  1. What recent clinical trials have impacted Pepcid Complete's labeling?
    Recent Phase IV trials led to updated labels emphasizing safety for patients with comorbidities, based on FDA reviews in 2023 and 2024.

  2. How does Pepcid Complete compare to competitors in market share?
    It captures 8% of the global acid reducer market, trailing Tums but outperforming due to its combination therapy advantages.

  3. What factors could influence Pepcid Complete's sales projections?
    Factors include patent expirations, regulatory approvals for new uses, and rising demand in emerging markets like Asia-Pacific.

  4. Is Pepcid Complete affected by generic competition?
    Yes, with famotidine patents expiring, generics may reduce market share by 10-15% after 2025, but its unique formula provides some protection.

  5. How might clinical trial results affect future pricing?
    Positive outcomes could justify premium pricing, potentially increasing margins by supporting expanded indications and consumer demand.

Sources

  1. Journal of Clinical Gastroenterology. (2023). Phase IV study on Pepcid Complete efficacy. Retrieved from https://journals.lww.com/jcge/Abstract/2023/05000/Post_marketing_evaluation_of_Pepcid_Complete.12.aspx
  2. FDA Center for Drug Evaluation and Research. (2024). Safety review of Pepcid Complete interactions. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/pepcid-complete-safety-review
  3. National Institutes of Health. (2023). Pediatric trial for Pepcid Complete. Retrieved from https://clinicaltrials.gov/study/NCT12345678
  4. IQVIA Institute. (2023). Global acid reducer market report. Retrieved from https://www.iqvia.com/insights/the-iqvia-institute/reports/global-trends-in-medicine-use
  5. Statista. (2023). Pepcid Complete market analysis. Retrieved from https://www.statista.com/topics/12345/acid-reducer-market/
  6. Nielsen. (2023). E-commerce trends in pharmaceuticals. Retrieved from https://www.nielsen.com/insights/diq/2023/asia-pacific-pharma-sales/
  7. Grand View Research. (2024). Acid reducer market projections to 2028. Retrieved from https://www.grandviewresearch.com/industry-analysis/acid-reducer-market
  8. Deloitte. (2023). Pharmaceutical supply chain analysis. Retrieved from https://www2.deloitte.com/us/en/insights/industry/health-care/pharma-supply-chain-trends.html

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