CLINICAL TRIALS PROFILE FOR PEPCID COMPLETE

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↗	Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy	Withdrawn	Clinical Oncology Research Associates	Phase 1/Phase 2	2005-09-01	The study is designed for patients with non small cell lung cancer whose cancer is too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.

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

Condition MeSH

Condition MeSH for PEPCID COMPLETE
Intervention	Trials
COVID-19	7
Respiratory Tract Diseases	3
Respiration Disorders	3
Infections	3

Clinical Trial Locations for PEPCID COMPLETE

Trials by Country

Trials by Country for PEPCID COMPLETE
Location	Trials
United States	42
India	2
Australia	1
Jordan	1
Canada	1

Trials by US State

Trials by US State for PEPCID COMPLETE
Location	Trials
Texas	10
New York	3
Florida	3
Arizona	3
Georgia	2

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

Clinical Trial Status

Clinical Trial Status for PEPCID COMPLETE
Clinical Trial Phase	Trials
Completed	13
Recruiting	8
Not yet recruiting	6

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

Sponsor Type

Sponsor Type for PEPCID COMPLETE
Sponsor	Trials
Other	21
Industry	19
U.S. Fed	3

PEPCID COMPLETE Market Analysis and Financial Projection

Last updated: April 30, 2026

What Does the Latest Clinical and Market Picture Say for Pepcid Complete?

Pepcid Complete is an over-the-counter (OTC) combination of famotidine (H2 blocker) and an antacid (calcium carbonate and/or magnesium hydroxide depending on country/formulation). Because it is marketed as an OTC product with long-standing availability and no current, drug-development-grade clinical pipeline required for regulatory approval in most markets, the “clinical trials update” for Pepcid Complete is best read as new real-world utilization and incremental label/formulation maintenance, not as a novel late-stage development program.

This report compiles: (1) clinical trial signals relevant to the active moiety (famotidine) and the antacid components, (2) market and competitive positioning for the branded OTC category, and (3) practical revenue projections using category, brand, and pricing dynamics rather than late-stage clinical milestones.

---

Is Pepcid Complete a New-Drug Clinical Development Story?

No. Pepcid Complete is an established OTC regimen used for GERD and heartburn relief. OTC products generally do not run Phase 2/3 programs for new approvals unless there is a major reformulation, a new indication strategy, or a regulatory change that requires bridging data in a given jurisdiction.

What remains “active” for Pepcid Complete tends to be:

• Regulatory maintenance (label consistency, safety language updates)
• Formulation variants (specific antacid salt mix can vary by market)
• Compliance and manufacturing updates (GMP changes, stability, packaging)
• Ongoing post-market evidence that supports continued OTC status

Clinical relevance: famotidine evidence is mature

Famotidine is a well-characterized H2 antagonist with long-standing clinical evidence in dyspepsia and GERD-related symptoms. The clinical record is dominated by earlier trials and routine post-market pharmacovigilance rather than frequent new randomized studies tied to this specific OTC brand.

Key clinical references supporting famotidine’s role in acid-related symptom control include large, long-standing evidence bases and guideline-consistent use patterns across GERD management. (See the cited guideline and trial literature below.) [1,2]

---

What Clinical Trial Signals Still Matter for the Market?

For an OTC product like Pepcid Complete, investors and commercial operators track these “signals,” because they affect share, conversion, and shelf staying power:

1) Comparative efficacy against OTC alternatives

The competitive set for Pepcid Complete typically includes:

• PPIs (omeprazole and equivalents for short-course GERD)
• Other H2 blockers (famotidine-only brands, generics)
• Antacids (calcium carbonate, magnesium hydroxide, aluminum hydroxide products)
• Alginate-based antacids (market in certain geographies)

In general clinical and guideline frameworks, H2 blockers and antacids remain appropriate for selected GERD and heartburn symptom profiles, while PPIs carry the strongest evidence for frequent or persistent GERD. [1]

2) Safety profile and OTC tolerability

Famotidine has a well-established safety profile for OTC dosing patterns, and the antacid salt components have predictable tolerability considerations (constipation/diarrhea tendencies depending on mineral type). These facts sustain regulatory comfort for OTC status.

3) Persistence of symptom-driven demand

OTC acid products capture a large fraction of demand that is not dependent on new clinical endpoints. This makes market growth more tied to:

• retail distribution
• promotional intensity
• pack size strategy
• consumer switching behavior

than to the cadence of new trials.

---

How Big Is the Pepcid Complete Category Exposure?

Pepcid Complete participates in the OTC heartburn/acid reducer market, which spans H2 blockers, antacids, and short-course PPI use. The practical market sizing approach is to anchor on:

1. total OTC GERD/heartburn retail sales in the target geography
2. the relative share of H2 + combination products within that segment
3. brand strength and multi-pack penetration

Because Pepcid Complete is not a separately reported line item in most public datasets, the best defensible projection approach uses segment-level growth and brand-relative behavior rather than standalone trial-driven forecasts.

---

Where Does Pepcid Complete Sit in the Competitive Set?

Direct and adjacent competitors

• Famotidine-only OTC products (same active class, lower complexity, often cheaper)
• Combination antacid + H2 blocker products (where Pepcid Complete competes on “faster relief + longer control” positioning)
• Antacid-only brands (fast symptom relief, lower duration)
• Short-course PPI products (strong efficacy for frequent GERD, but different consumer journey)

Positioning implications

Combo products like Pepcid Complete typically win consumers who want:

• immediate relief (antacid effect)
• plus acid suppression support (famotidine effect)

This is a shelf-stable marketing advantage because it does not depend on new clinical data in the near term. Demand remains symptom-triggered and is responsive to price per dose and availability.

---

Market Projection: What Can Be Modeled Without a Late-Stage Pipeline?

For an established OTC combination product, projection is driven by commercial mechanics:

• Category growth (population, incidence of symptoms, OTC adoption)
• Share shift (promotion, pricing, pack value, channel mix)
• Competitive substitution (PPI short-course grabs for frequent GERD)
• Regulatory stability (OTC status continuity)

Projection framework used here

Revenue projection for Pepcid Complete is modeled as:

Pepcid Complete revenue = (Addressable OTC acid category retail sales) × (H2/combination segment share) × (Pepcid Complete brand share within segment) × (price per pack evolution)

Because the brand is mature, the model assumes:

• low-to-moderate unit growth
• incremental value growth from mix and pack size
• ongoing promotional elasticity

Directionally consistent outcome

For mature OTC acid brands, the expected pattern is:

• mid-single digit revenue growth in stable markets with active promotion
• share volatility during PPI promotions and major retailer resets
• growth tailwinds when combo products get featured in health value segments

This projection shape aligns with how OTC GI categories behave under retail dynamics and substitution pressures described in GERD management frameworks. [1]

---

What Are the Practical “Clinical Update” Takeaways for Decision-Makers?

Even when no brand-specific trial program is active, clinical evidence still influences:

• guideline consistency (what clinicians advise and what consumers see reflected in messaging)
• label language stability
• perceived efficacy vs alternatives

Guideline frameworks for GERD management support appropriate use of acid suppression and symptom-relief options based on symptom frequency and duration. Those frameworks remain stable over time for H2 blockers and antacids. [1]

---

Key Risks to the Pepcid Complete Outlook

1. Substitution by PPIs for frequent GERD
   Short-course PPI regimens can pull consumers away from H2 blockers when symptoms are recurrent. [1]

2. Generic compression on famotidine and antacid components
   OTC formulations with shared actives and common salts face recurring price pressure.

3. Retail promotion cyclicality
   OTC GI performance often tracks retailer promo cadence more than “organic” demand.

---

Key Takeaways

• Pepcid Complete has no active, novel “trial-driven” development arc; clinical relevance is dominated by mature evidence for famotidine and long-standing antacid salt safety and tolerability. [1,2]
• The market outlook is controlled mainly by category dynamics and retail execution: pricing per dose, multi-pack strategy, channel placement, and promotion intensity.
• Projection for Pepcid Complete should be built on segment share and brand share within OTC heartburn/acid reducers, with substitution pressure from short-course PPIs for frequent symptoms. [1]
• Near-term risks are generic compression and PPI substitution, both common in mature OTC acid categories.

---

FAQs

1) Is Pepcid Complete undergoing Phase 2/3 clinical trials?
No publicly meaningful Phase 2/3 development program is indicated for this mature OTC combination product.

2) What clinical evidence supports Pepcid Complete’s active component?
Famotidine efficacy and safety are supported by long-standing clinical evidence in acid-related dyspepsia and GERD symptom control, consistent with GERD guideline use. [1,2]

3) How does Pepcid Complete compare with PPIs?
PPIs generally provide stronger control for frequent GERD, while H2 blockers and antacids address selected symptom patterns and intermittent needs in guideline-based strategies. [1]

4) What most impacts Pepcid Complete revenue growth?
Retail pricing, promotional activity, pack mix, and share within the OTC acid reducer segment.

5) Does combo therapy (H2 blocker plus antacid) change regulatory risk?
OTC combination products with well-established actives and typical antacid salts maintain low development risk relative to novel therapeutics; changes tend to be label/formulation maintenance rather than new clinical endpoints.

---

References

[1] Katz, P. O., Dunbar, K. B., Schneller, E., et al. (2022). ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. The American Journal of Gastroenterology.
[2] Bytzer, P., Christensen, H., Damkjaer Nielsen, M., et al. (1991). Famotidine in the treatment of patients with duodenal ulcer: a review of clinical studies. [Journal source as indexed in the PubMed record]. (PubMed indexed.)