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Opioid-induced constipation

0 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Opioid-induced constipation

13 trials tracked for Opioid-induced constipation: 7 in phase 3 or 4 and 6 with published results. The most-cited published study has 510 citations.

13Trials tracked
7Phase 3 & 4
0Recruiting
6With published results
Phase distribution
Phase 4 3 Phase 3 4 Phase 2 5 Other / NA 1
  1. Phase 4 To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation Completed · 510 cited
  2. Phase 4 Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness Completed · 94 cited
  3. Phase 3 Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation Completed · 20 cited
  4. Phase 3 Long Term Safety of Naldemedine Completed · 20 cited
  5. Phase 3 Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation Completed · 20 cited
  6. Phase 3 A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain Completed · 7 cited
Show 7 more trials
  1. Phase 4 Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness Completed
  2. Phase 2 Evaluation of the Efficacy and Safety of ADL5945 for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain Completed
  3. Phase 2 Naloxone SR Capsules in Patients With Opioid Induced Constipation Completed
  4. Phase 2 A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy Completed
  5. Phase 2 Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures Completed
  6. Phase 2 Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain Completed
  7. N/A Compassionate Use Study of Methylnaltrexone Completed

Showing the 13 most-cited and recently-updated of 13 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Opioid-induced constipation: what the trials found

Naldemedine has demonstrated significant efficacy in improving spontaneous bowel movements (SBM) and overall constipation symptoms. Trials showed a statistically significant increase in the number of SBMs per week from baseline to both Week 1 and the final two weeks of treatment [4, 6]. Specifically, Naldemedine was associated with an increase of approximately 3.42 to 3.88 SBMs per week compared to placebo [4, 5, 6], while also significantly reducing scores on patient assessment scales for constipation symptoms 5.

Methylnaltrexone is associated with rapid laxation responses and increased bowel movement frequency. Evidence indicates a high proportion of subjects achieved rescue-free laxation within 4 hours of dosing 2 and significant improvements in the number of laxations per week 3. Furthermore, methylnaltrexone demonstrated a statistically significant increase in the percentage of participants achieving a laxation response within both 2 and 4 hours of the first dose compared to placebo 8.

While multiple studies evaluated methylnaltrexone for OIC, results regarding specific responder rates over 4 weeks showed no statistically significant difference between treatment arms 7. Additionally, patient preference data suggests that while certain medications like Movantik and PEG 3350 were compared in terms of Bowel Function Index (BFI) scores, there was no statistically significant difference in patient reported preference between the two treatments 1.

Recent results — preliminary, needs further review

  • Linaclotide (145 micrograms) showed a statistically significant increase in 8-week SBM frequency rates compared to other groups, though results for responder criteria and time to first SBM did not reach statistical significance 9.
  • Naloxone SR (5 mg) is currently under investigation but lacks established outcome data in the provided evidence 12.

For the clinician treating this condition

  • Naldemedine provides a statistically significant increase in spontaneous bowel movements and improved patient-reported constipation scores [4, 5, 6].
  • Methylnaltrexone is associated with rapid laxation responses (within 2-4 hours) and increased weekly laxations [2, 3, 8].
  • Clinical data indicates that while methylnaltrexone improves movement frequency, specific responder rates over a 4-week period did not show statistically significant variance between groups 7.

AI synthesis of 8 cited trials, updated Aug 27, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
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